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The Zacks Analyst Blog Highlights: Regeneron Pharmaceuticals, Incyte, Nektar Therapeutics, Immunome and Otonomy

By Zacks Investment ResearchStock MarketsFeb 25, 2021 05:50AM ET
www.investing.com/analysis/the-zacks-analyst-blog-highlights-regeneron-pharmaceuticals-incyte-nektar-therapeutics-immunome-and-otonomy-200563198
The Zacks Analyst Blog Highlights: Regeneron Pharmaceuticals, Incyte, Nektar Therapeutics, Immunome and Otonomy
By Zacks Investment Research   |  Feb 25, 2021 05:50AM ET
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For Immediate Release

Chicago, IL – February 25, 2021 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. REGN, Incyte (NASDAQ:INCY) Corporation INCY, Nektar Therapeutics (NASDAQ:NKTR) NKTR, Immunome, Inc. IMNM and Otonomy (NASDAQ:OTIC), Inc. OTIC.

Here are highlights from Wednesday’s Analyst Blog:

Biotech Stock Roundup: Post-Earnings Edition

The biotech sector continues to be in focus with regulatory and pipeline updates from quite a few companies. New drug approvals are also in the spotlight. The sector has also been in focus, thanks to the development of antibodies and vaccines for coronavirus gaining importance with each passing day.

Recap of the Week's Most Important Stories:

Regeneron Obtains FDA Nod for Libtayo in NSCLC: Regeneron Pharmaceuticals and partner Sanofi (NASDAQ:SNY) obtained FDA approval for a label expansion of their PD-1 inhibitor, Libtayo (cemiplimab-rwlc). The drug is now approved for the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test.

Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials. Earlier this month, the drug was approved as the first immunotherapy for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, with full approval granted for locally advanced disease and accelerated approval granted for metastatic disease.

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

Regulatory Updates from Incyte: Incyte announced that the FDA has accepted for Priority Review its supplemental New Drug Application (sNDA) for lead drug, Jakafi (ruxolitinib), for the treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. The agency generally grants Priority Review to drugs that offer a major advancement in treatment where none currently exists. This designation shortens the review period to six months compared to 10 months for Standard Review. The target action date for this indication is Jun 22, 2021.

Separately, the agency has also accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

Nektar Up on Agreement With Merck: Shares of Nektar Therapeutics gained after it announced an agreement with pharma giant Merck for a phase II/III study of the former's bempegaldesleukin (NKTR-214, BEMPEG) in combination with the latter's blockbuster immuno-oncology drug, Keytruda, for the first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN), whose tumors express PD-L1.

Per the terms, Nektar will conduct the above-mentioned study, which is expected to enroll 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors. The company will conduct the above-mentioned study, which is expected to enroll 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors.

These patients will be randomized to receive either the combination of bempegaldesleukin and Keytruda or only Keytruda. The phase II portion of the study will include an interim analysis of the overall response rate (ORR) after the first 200 patients enrolled have a minimum follow-up of 4 months. The study will be continued only if the ORR passes a prespecified futility boundary.

Immunome Surges on Antibodies Update: Shares of Immunome surged after it announced that its discovery engine has isolated potent antibodies capable of neutralizing several SARS-CoV-2 variants, including the South African Variant (B.1.351), in pseudovirus testing. The company is developing a cocktail of antibodies targeting spike and non-spike proteins that can serve as a prophylaxis or treatment for COVID-19.

Immunome has identified antibodies that bind to non-overlapping regions of the spike protein, including those regions containing the critical mutational variants while developing the antibody cocktail (IMM-BCP-001).

Otonomy Plunges on Study Data: Shares of Otonomy plunged significantly after it announced that the late-stage study of Otividex was not successful. The phase III study of Otividex in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in month 3 for Otividex as compared to placebo for the intent-to-treat (ITT (NYSE:ITT)) population (n = 148; p value = 0.312) using the Negative Binomial Model. The results did show statistical significance for the per protocol (PP) population.

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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.


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Regeneron Pharmaceuticals, Inc. (REGN): Get Free Report

Incyte Corporation (INCY): Free Stock Analysis Report

Nektar Therapeutics (NKTR): Free Stock Analysis Report

Otonomy, Inc. (OTIC): Free Stock Analysis Report

Immunome, Inc. (IMNM): Free Stock Analysis Report

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The Zacks Analyst Blog Highlights: Regeneron Pharmaceuticals, Incyte, Nektar Therapeutics, Immunome and Otonomy
 

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The Zacks Analyst Blog Highlights: Regeneron Pharmaceuticals, Incyte, Nektar Therapeutics, Immunome and Otonomy

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